Fraud and Abuse; Removal of Safe Harbor Protection for Rebates Involving Prescription Pharmaceuticals and Creation of New Safe Harbor Protection for Certain Point-of-Sale Reductions in Price on Prescription Pharmaceuticals and Certain Pharmacy Benefit Manager Service Fees, 7815 [2021-02132]

Agencies

• DEPARTMENT OF HEALTH AND HUMAN SERVICES
• Office of Inspector General

[Federal Register Volume 86, Number 20 (Tuesday, February 2, 2021)]
[Rules and Regulations]
[Page 7815]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-02132]



[[Page 7815]]

-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Office of Inspector General

42 CFR Part 1001

RIN 0936-AA08


Fraud and Abuse; Removal of Safe Harbor Protection for Rebates 
Involving Prescription Pharmaceuticals and Creation of New Safe Harbor 
Protection for Certain Point-of-Sale Reductions in Price on 
Prescription Pharmaceuticals and Certain Pharmacy Benefit Manager 
Service Fees

AGENCY: Office of Inspector General (OIG), Health and Human Services 
(HHS).

ACTION: Final rule; delay of effective date; correction.

-----------------------------------------------------------------------

SUMMARY: In accordance with the memorandum of January 20, 2021, from 
the Assistant to the President and Chief of Staff, entitled 
``Regulatory Freeze Pending Review,'' and given the pendency of 
litigation, Pharmaceutical Care Management Association v. U.S. 
Department of Health and Human Services, et al., Civil Action No. 21-95 
(JDB) (D.D.C.), challenging the final rule, this action temporarily 
delays for 60 days from the date of the memorandum the effective date 
of certain amendments as promulgated by the final rule titled ``Fraud 
and Abuse; Removal of Safe Harbor Protection for Rebates Involving 
Prescription Pharmaceuticals and Creation of New Safe Harbor Protection 
for Certain Point-of-Sale Reductions in Price on Prescription 
Pharmaceuticals and Certain Pharmacy Benefit Manager Service Fees,'' 
published in the November 30, 2020, Federal Register. This document 
announces that the effective date for the certain provisions of the 
final rule is delayed until March 22, 2021, the first business day 
after 60 days from the date of the memorandum. This document also 
corrects a technical error in the amendatory instructions.

DATES: As of January 29, 2021, the effective date of the amendments to 
42 CFR 1001.952 (h)(6) through (9), (cc), and (dd) published at 85 FR 
76666, November 30, 2020, is delayed until March 22, 2021.
    This correction is effective as of March 22, 2021. The amendatory 
instructions in FR 2020-25841 (85 FR 76666), published on November 30, 
2020 is corrected.

FOR FURTHER INFORMATION CONTACT: Aaron Zajic, (202) 619-0335.

SUPPLEMENTARY INFORMATION: The January 20, 2021 memorandum from the 
Assistant to the President and Chief of Staff, entitled ``Regulatory 
Freeze Pending Review,'' instructed Federal agencies to consider 
delaying the effective date of rules published in the Federal Register, 
but which have not yet taken effect, for a period of 60 days from the 
date of the memorandum to permit review of the rule. This action is 
consistent with that memorandum insofar as the Department has decided 
to review the rule at issue, and needs time to determine what 
additional action, if any, is appropriate.
    The Department also has good cause to delay this rule's effective 
date without advance notice and comment under 5 U.S.C. 553(b)(B) 
because of the pendency of litigation challenging the final rule, and 
the Department's interest in evaluating its position in that 
litigation. The litigation includes both procedural and substantive 
challenges to the rule and its effective date. Though the provisions of 
the rule being delayed by this notice do not fully overlap with the 
provisions at issue in the pending litigation, the intersections 
between the rule's various provisions and the overall regulatory 
framework are complex. HHS intends to evaluate those interactions as 
part of its regulatory review process, but needs additional time to do 
so beyond the current effective date of January 29, 2021.
    Accordingly, this final rule delays the effective date of certain 
portions of the safe harbor regulation concerning discounts for 
prescription pharmaceutical products at 42 CFR 1001.952. The effective 
date of new paragraphs (h)(6) through (9), (cc), and (dd) of that rule, 
which would have been January 29, 2021, is now March 22, 2021. The 
temporary delay in the effective date of this final rule is necessary 
to give Department officials the opportunity for further review and 
consideration of the revisions to paragraphs (h)(5)(vi) and (viii), as 
well as the addition of new paragraphs (h)(5)(iii), (6) through (9), 
(cc), and (dd) of 42 CFR 1001.952, consistent with the memorandum of 
January 20, 2021.
    Separately, November 2020 final rule contained a technical error in 
the amendatory instructions that would have prevented the Office of the 
Federal Register from properly incorporating the amendments to Sec.  
1001.952 into the CFR. This document also corrects that error.

0
In FR 2020-25841 (85 FR 76666), published on November 30, 2020, the 
following corrections are made:


Sec.  1001.952   [Corrected]

0
1. On page 76730, third column, instruction 2 (including a. and b.) is 
corrected to read as follows:
0
2. Section 1001.952 is amended by adding paragraphs (h)(6) through (9), 
(cc), and (dd) to read as follows:


Sec.  1001.952   [Corrected]

0
2. On page 76731, first column, Sec.  1001.952 is corrected by removing 
``(5) * * * '', and the text of paragraphs (vi) through (viii).


Sec.  1001.952   [Corrected]

0
3. On page 76731, third column, add amendatory instruction 3 to read as 
follows:
    3. Effective January 1, 2022, Sec.  1001.952 is amended by revising 
paragraphs (h)(5)(vi) and (vii) and adding paragraph (h)(5)(viii) to 
read as follows:


Sec.  1001.952   Exceptions.

* * * * *
    (h) * * *
    (5) * * *
    (vi) Services provided in accordance with a personal or management 
services contract;
    (vii) Other remuneration, in cash or in kind, not explicitly 
described in this paragraph (h)(5); or
    (viii) A reduction in price or other remuneration in connection 
with the sale or purchase of a prescription pharmaceutical product from 
a manufacturer to a plan sponsor under Medicare Part D either directly 
to the plan sponsor under Medicare Part D, or indirectly through a 
pharmacy benefit manager acting under contract with a plan sponsor 
under Medicare Part D, unless it is a price reduction or rebate that is 
required by law.
* * * * *

Norris Cochran,
Acting Secretary.
[FR Doc. 2021-02132 Filed 1-29-21; 8:45 am]
BILLING CODE 4152-01-P